Registration of Drug License in India:

Guidelines for Grant of Licences for Sale of Drugs under Drugs & Cosmetics Act, 1940 and Rules thereunder:

Introduction:

Drugs are essential for ensuring good health of a Nation. Drugs are
different from other commodities and because of that the Government has laid
down stringent law. Regulation governing manufacture & sale of drugs are
in the Drugs and Cosmetics Act, 1940 and Rules framed thereunder. Control is
exercised over drugs from the raw material stage during manufacture, sale, and
distribution and up to the time it is passed-on to a patient or consumer by a
Pharmacist in retail Pharmacy, Hospital or a Dispensary.

General Instructions: 1. Applicant has to obtain user ID and Password by giving request online on with the details of the firm.
2. All the documents should be scanned in 100 dpi & black and white, and then should be uploaded using the said ID and Password at space provided for the purpose.
3. Please show all the original documents to the inspector at the time of inspection.
4. Please be sure that, all the information is filled precisely for respective application mentioned below and only then e-send the application. In case of rejection of your application for incomplete information, the fees once paid will be forfeited.
5. The licensing authority may ask for any other specific documents if required.
6. These guidelines are subject to change as and when required and will be notified from time to time.
7. Every application needs to be ‘e-send’, or it will not be inwarded to the office the proprietor/ partner are changed, it will be treated as ‘change in constitution’ and applicant will have to obtain a fresh license.
8. After grant or rejection of your application, you will receive an SMS about the same. Take a print out of the approval/rejection from ‘Print License’ option for fresh license and renewal and click ‘MISC approvals’ for other approvals within 3 days. You will receive licenses/approvals with the valid e-signature and official seal.
9. Registered Pharmacists are also required to update their details by obtaining separate password.
10. These are only guidelines. The Provisions of Drugs and Cosmetic Act 1940 and Rules 1945 will always prevail.